Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

Overview Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device. This document pertains to the objectives and processes for post-market surveillance for medical devices conducted by manufacturers with the assistance of their economic operators, as well as market surveillance conducted by regulators, and the role of other stakeholders in these processes. It describes the measures taken to ensure the ongoing compliance of medical devices with the requirements for safety, quality, and performance after they are placed on the market.

REFERENCE NUMBERS ISBN:

978-92-4-001531-9

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